I refer to Dr. Mahinda de Silva (MdeS)’s response of 22nd January to my article which appeared in The Island on 16th January under the title ‘The debate on generic drugs – a layman’s point of view’. MdeS seems obviously peeved that a layman has entered a debate which should be left in the hands of medical professionals, without realizing who the key stakeholders in this vital discourse are. He would rather like lay men and women to shut up! (Hence, epithets like Don Quixote!)

Incidentally, let me say I never introduced myself as "the public’s appointed spokesman" as he tries to make out, by using those words within quotes. I did say I represent the public interest, adding the words "as perhaps their self-appointed spokesman!" within parenthesis. Not many would have failed to see the difference!

The problem of definitions

In his very first intervention in this debate (9th January), Dr.MdeS defined a generic drug as "an exact copy of a brand name drug whose patent has expired", which he admits to have modified in the second article he wrote on the subject. What is significant, anyway, is that he does not contest the Merck Manual classification that I brought to the notice of the reader, according to which there are three names associated with drugs viz.(i) chemical name, (ii) generic (official) name and (iii) trade (proprietary or brand) name.

Yet, he proceeds to accuse me of taking the Merck definition too literally, as if definitions can be taken metaphorically or figuratively! I am not aware that they do so in the medical profession! These are his words,: "Quoting from his Merck Manual’s definition of a generic drug, Mr. EdeS sees a difference from my definition, which is causing him confusion. Of course, he does not have the insight to wonder whether he might be misrepresenting what his Merck Manual says, by taking its information too literally". I do not, of course, claim to have the "insight to wonder" which he seems to have in abundance, making him see no difference between the Merck Manual definition and his own which says "the chemical name = the generic name".

Since Dr. MdeS, with 23 years of experience as a medical practitioner in USA, has repeatedly referred to the Federal Drug Authority (FDA) of that country, and has patronizingly suggested that I log on to the internet myself "or with the aid of another", let me quote for his benefit and that of the readers what the FDA Consumer Magazine (July-August 2005) says on the subject of Drug Name Confusion, with emphasis added:

"Every drug usually has three names: chemical, generic (non-proprietary), and brand (proprietary) names, and each is subject to different rules and regulations.

The chemical name specifies the chemical structure of the drug. It is not preapproved by any organization, nor is it recognized in any standard manuals, such as USP publications. Therefore, chemical names are primarily used by researchers, but not in medical practice.

The FDA requires that either the established, or official, name or in the absence of an official name, the common or usual name, appears on labels and labeling of a drug product. The common name, loosely referred to as the generic name, must accompany the brand name, if there is one ……….

The generic name is usually created for drug substances when a new drug is ready for marketing. It is selected by the United States Adopted Names (USAN) Council, whose expertise is recognized by the FDA, according to principles developed to ensure safety, consistence, and logic. These names are typically used by health care professionals.

Generic names are coined using an established stem, or group of letters that represents a specific drug class……………….Names that include such stems , chemistry roots, or any other coded information are easier to remember, and give clues about what a drug is used for.

The brand name, also called trademark, can be created as soon as a generic name has been established. Only brand names of products subject to a new drug application or an abbreviated new drug application must be approved by the FDA first. This requirement distinguishes them from generic names."

This should help us to lay at rest the debate on definitions, and move on to the larger issue which Dr. D.P. Atukorale (DPA) brought to our attention and has, since then, generated a lot of hot air. The question is how will the government’s decision to compel doctors to prescribe drugs by their generic names, hailed by my friend Prof. Carlo Fonseka (CF) as a "giant step to be taken by Hon. Nimal Siripala de Silva", impact on their lives?

Generic prescribing does not, naturally, pose major problems in a country like US in view of their strict regulatory arrangements to ensure the quality of both the generic and branded drugs that come into the market, well-trained pharmacists, and greater rapport between the pharmacist and the doctor which enables the pharmacist to even consult the doctor before dispensing a prescription. "But that is in the United States, and we are here in Sri Lanka" as I said in my previous intervention.

As for Sri Lanka, MdeS refers to our DRA (Drug Regulatory Authority)’s failure to perform its basic function "either due to incompetence, malfeasance or both", and "the regulatory anarchy" that prevails as a result. He emphasizes that any drug approved by the DRA should be of the same quality, and as safe and effective as the brand drug (by this he appears to mean the original innovator drug). Having said that, he wonders whether it would not be wise for government to be the main if not the sole importer of essential drugs, given a competent and honest DRA without a conflict of interest, which is nowhere in the horizon!

Then he says that the DRA does not itself test drugs for quality. Neither can a National Quality Control lab be expected to have the ability to test the quality of myriads of drugs in the market, he says. He does not say whether such a lab would be able to do this if the number of drugs is reduced to a manageable number, as he himself suggests elsewhere. Then he proceeds to say "complaints regarding quality are directed to the DRA and the manufacturer who are the institutions that can resolve them" all of which make the DRA look like an intermediary and the manufacturer himself the final arbiter on quality. Thereafter he says that the manufacturer must supply the scientific and technological data to the scientists and technologists at the DRA who will pronounce on the quality of the drug! Those who have the "insight to wonder" may be able to make some sense out of all this!

In an article written to the Daily Mirror (23rd January), MdeS has expressed the hope that the debate on generic drugs is brought to a conclusion with the information he has supplied to that newspaper, which I find is no different from what he had said through the columns of The Island. It is my honest belief that he has not done much to enlighten us on the merits and demerits of the government decision, and the debate is still open.

Helping the poor, or hitting them?

DPA, in his latest piece in The Island (25th January), re-iterates that almost all the drugs used in our hospitals (both government and private) and the majority of drugs sold in our pharmacies including SPC are branded drugs; and that generic unbranded drugs (which he calls pure generics) are just a few. He also says, not for the first time, that most of the brand drugs that are available are of poor quality, and that we do not have facilities to test the quality of most of these. This is where a large part of the problem lies, and this is what Prof Sanath P. Lamabadusuriya so succinctly pointed out. Have the government’s official and unofficial advisers given attention to this? Why have Dr. Balasubramaniam and Prof. Carlo Fonseka got into a shell after their initial outburst? They should be able to answer the questions that agitate the public mind better than MdeS whose experience is more in US!

It is well known that a lot of generic unbranded and generic branded drugs are imported to this country from other South Asian countries. If you take India as an example there are high quality generic brands which doctors do freely prescribe instead of the innovator trade name drug. On a personal note, two of the three drugs that I presently take on a daily basis are manufactured in India. But that is not the end of the story. It is well known that drugs of poor or doubtful quality are made not only in India, but also in other countries from which we import. D.G.Dassanayake, an Island reader, says (27th January) he saw antibiotic capsules being ‘assembled’ inside houses during a visit to a South Indian low income urban community recently. No wonder the Indian government was concerned about spurious/ counterfeit/ substandard drugs made there, and appointed an Expert Committee a couple of years back to examine and report on all aspects of the problem. This Committee (known as the Mashelkar Committee) reported on serious inadequacies in the regulatory arrangements obtaining in India. Can those who have rushed in to applaud the recent decision taken by our Health Minister assure us that our own regulatory arrangements and purchasing procedures are sufficiently effective to prevent some of these spurious, counterfeit and substandard drugs reaching our sales or distribution outlets? If not, would not the champions of the poor be hitting the poorer segments of society the hardest?